Cytology Proficiency Improvement Act of 2008
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Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
April 9, 2008
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Introduced in House
February 28, 2007
Referred to the House Committee on Energy and Commerce.
February 28, 2007
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
March 11, 2008
Committee Consideration and Mark-up Session Held.
March 13, 2008
Ordered to be Reported (Amended) by Voice Vote.
March 13, 2008
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-566.
April 8, 2008
Placed on the Union Calendar, Calendar No. 348.
April 8, 2008
Mrs. Capps moved to suspend the rules and pass the bill, as amended.
April 8, 2008 • 3:26 PM
Considered under suspension of the rules. (consideration: CR H2029-2034)
April 8, 2008 • 3:26 PM
DEBATE - The House proceeded with forty minutes of debate on H.R. 1237.
April 8, 2008 • 3:26 PM
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H2029-2030)
April 8, 2008 • 3:35 PM
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H2029-2030)
April 8, 2008 • 3:35 PM
Motion to reconsider laid on the table Agreed to without objection.
April 8, 2008 • 3:35 PM
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
April 9, 2008
Floor Debate
13 membersWhat members said about H.R. 1237 on the floor
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Floor Debate
13 membersWhat members said about H.R. 1237 on the floor
I thank my friend and colleague from Georgia, Congressman Deal, for his leadership on this issue and for the time today. I also want to express my gratitude and thanks to Representative Gordon, who…
I thank my friend and colleague from Georgia, Congressman Deal, for his leadership on this issue and for the time today.
I also want to express my gratitude and thanks to Representative Gordon, who was extremely cooperative and helpful and productive throughout this entire process. I want to thank the American College of Pathology and all of the pathologists across the Nation who are working day in and day out to make certain that they provide quality care for the patients for whom they are charged.
Madam Speaker, I include in the Record a copy of an article by Dr. George Nagy that documents the dysfunctional federally mandated proficiency test in cytopathology.
The Dysfunctional Federally Mandated Proficiency Test in
Cytopathology--A Statistical Analysis
Proficiency testing in cytopathology and in other
disciplines should be based on firm statistical and
scientific foundations, because test theory in general is a
heavily statistical subject. Statistical considerations have
demonstrated that the design of ``short'' proficiency tests
in cytopathology, including the current federally mandated
test, fundamentally is unsound because of the lack of
sufficient validity and reliability. Examinees too frequently
are misclassified by such short-format tests: Competent
examinees fail the test in surprisingly high numbers, whereas
most of the examinees who have insufficient cytologic skills
eventually pass the test after the allowed retakes. Only
dichotomous tests are suitable for accurate computation of
the effects of test design on reliability, but the
statistical conclusions also are generalizable to
nondichotomous tests. In conclusion, the current federally
mandated proficiency test cannot reliably measure the level
of expertise of cytologists and, thus, cannot assure that
only adequately skilled individuals evaluate Papanicolaou
test samples. To render the test suitable for its intended
purpose, the authors believe that complete redesign of the
test, with the participation of experts in modern test
theory, would be advisable.
Proficiency testing in cytopathology (PTC), which was
established in the 1991 regulations to implement the Clinical
Laboratory Improvement Amendments of 1988 (CLlA'88), has only
recently been enforced on a national scale. For more than a
decade, during which logistical hurdles hampered the
development of a national program for PTC, there was not much
incentive to think about the value and potential of PTC or
its theoretical background or to worry that the test design
was so poor. In 2004, however, the Center for Medicare and
Medicaid Services announced that a national PTC program
developed by the Midwest Institute for Medical Education had
been approved and that the regulations finally would be
enforced on a national level. Suddenly, the shortcomings of
the test were everyone's problem. What followed was a flurry
of comments, articles, proposals, and Internet discussions
about the PTC and its future. Although the testing has
proceeded nationwide in conformity with the original
regulations, the dust has not yet settled on the subject. The
professional organizations agree that PTC, as prescribed in
CLIA'88, is inadequate and is in great need of improvement if
indeed it should remain in place at all. Regarding the
projected revisions, it is a real impediment that some
regulatory authorities that are in a position to make
decisions about the implementation of PTC apparently are
not familiar with most of the theoretical implications of
test theory, which is an exceedingly complicated subject.
So long as the test is mandatory for every practitioner of
gynecologic cytopathology in the United States, it is in
the best interest of all participants for PTC to become a
scientifically well-founded, valid, and reliable quality
assurance method. In the current article, we have
attempted to shed light on some gaps in the knowledge
about the theoretical underpinnings of PTC that seem to
endure in the cytopathology literature.
test theory is statistical
Test theory is a heavily statistical subject. Virtually all
aspects of test theory have been investigated in depth almost
exclusively by educators and psychologists, which is
understandable, because testing is a central issue in their
disciplines. Unfortunately, this valuable body of literature
apparently has been disregarded completely by the federal
authorities that are responsible for PTC regulations.
The statistical apparatus used in modern test theory is
formidable. Many books and
articles written about the subject use highly sophisticated
mathematical tools, including differential and integral
calculus and matrix algebra. One of the reasons for the high
degree of mathematization of test theory in psychology and
education science is that these disciplines deal largely with
intangibles, like motivation, intelligence, understanding,
and adaptability, which are not directly measurable. Such
entities must be studied indirectly, through measurements of
other quantities. That is why psychological test theory
introduced the concept of ``constructs'' that can substitute
for and represent the kinds of abstract attributes mentioned
above. Even so, the highly complicated mathematical and
statistical tools that have been promoted in educational and
psychological test theory fulfill mainly academic purposes.
Most actual problems in everyday testing can be solved on a
practical level that does not use highly complicated
mathematical methods but, at the same time, does not
disregard basic statistical principles.
testing in the physical and biologic sciences
Cytopathology, unlike educational science or psychology, is
an applied natural science, and this is one of the reasons
why PTC can be performed without the application of overly
sophisticated mathematical tools. Interpretation of
Papanicolaou smears, reproduction of cytologic diagnoses, and
measurement of false-negative proportions, among others, are
very complex tasks. By comparison, technically, it is a
comparatively straightforward matter to evaluate the
examinees' ability to assign diagnostic categories to
cytologic changes observed on a slide or computer screen.
Thus, abstract constructs hardly are needed in PTC.
Nevertheless, a certain level of mathematical and statistical
understanding by the designers of the test is crucial if a
fair and scientifically valid system of PTC is to be
established. Most pathologists, including ourselves, do not
have rigorous training in statistics; therefore, if PTC is to
continue, then the regulatory authorities ought to contract
with experts in statistics and test theory who, through
interaction with knowledgeable cytopathologists and
cytotechnologists, would design an equitable and
scientifically well-founded system for the nationwide PTC.
We do not mean to suggest that statisticians have not
participated in the design of cytology testing programs. In
fact, the College of American Pathologists' (CAP)
Interlaboratory Comparison Program for Cervicovaginal
Cytology was designed, implemented, and monitored with the
extensive help of statistical expertise. However, this
educational endeavor was not intended to be a PTC program as
envisioned in the federal regulations. In fact, its original,
scientifically and statistically supported structure
ironically prevented its use as a PTC program because of the
specific requirements of the federal regulations.
short tests and reliability
One of the central problems in the practice of PTC is
reliability, and the reliability of PTC is related closely to
the size of the test sets (the number of the test items or
challenges in 1 test set). ``Short'' tests, which require the
evaluation of relatively small numbers of slides, are
characterized by a high misclassification rate. (The
pervasive effect of sample size on the reliability of
statistical inference is the reason why pollsters use large
samples: The larger the sample, the narrower are the
confidence limits in relative terms. The statistical
estimates inferred from a single sizable sample that has been
chosen by randomization will approach the true parameters of
the population.) Short tests will not prevent the frequent
failure of competent examinees or the passing of examinees
who have less than desirable skill levels. Already in 1991
one of us (G.K.N.), in a report that was written with D.C.
Collins, emphasized that the expected misclassification
rate of such short tests can be surprisingly high and
that, in the case of dichotomous tests, this rate can be
calculated (or approximated) through the use of the
binomial theory of statistics. (A dichotomous test
evaluates the responses to test items as ``right'' or
``wrong,'' without using intermediate results or weighing
of answers. The PTC system used in New York State for 36
years was dichotomous and so was the original
Interlaboratory Comparison Program in Cervicovaginal
Cytology. The CLIA'88-mandated PTC is not dichotomous.)
This so-called ``simple binomial error model'' was
described in test theory initially in the 1950s.
The results of the CLIA'88 mandated national PTC in 2005
dramatically demonstrated the effect of misclassification
during short tests, as described previously. According to the
data from the National Cytology Proficiency Testing Update,
9% of the examinees failed the test when they attempted it
for the first time. However, when this group that supposedly
had inferior skills retook the test, curiously, the failure
rate for this second attempt was similar to that for the
entire original group (10%). It appears that the cytologic
skills among those examinees who had failed originally
improved miraculously, allowing 90% of them to pass the
examination, although all of them initially failed. It is
hard to believe that a short remedial training between the
first and second attempt could result in such an impressive
real improvement. The only plausible scientific explanation
is the well-known statistical phenomenon, the Galtonian
``regression toward the mean.'' The majority of failures
during the first attempt were the consequence of
misclassification because of the poor validity and
reliability of the short test and were not caused by the
insufficient skills of those who failed. The failure rate in
all groups of examinees is about the same on the first
attempt and on the second attempt, and previous failures do
not seem to matter much. Essentially, the results of the
CLIA'88-mandated PTC mostly mirror the statistical chances
and not the examinees' skills.
Of course, multiple other variables beyond regression
toward the mean, including experience gained in the technique
of the test, differences in the difficulty of particular test
sets, and even increased skills after remedial training, etc,
also may play a role in the improvement of test results at
the second attempt for individual examinees. However, to
date, we do not have any data or even a plausible explanation
concerning how any of these other factors, with the exception
of regression toward the mean, could produce such a
consistent result.
The Simple Binomial Error Model
Misclassification of examinees by any short test, including
the CLIA'88-mandated PTC, can be demonstrated by means of an
analogy. Strictly speaking, this analogy is applicable only
to dichotomous testing systems. However, in this sense,
dichotomous and non dichotomous systems are correspondent.
For statistical or evaluation purposes, non dichotomous
systems can be made dichotomous at any time, even after the
tests have been carried out. For example, an answer can be
evaluated as correct only if it falls into the appropriate
single category (``success'') and all other answers are rated
as wrong (``failure''). Another solution to this problem in
PTC would be to restrict the number of diagnostic categories
to 2, with 1 category, for instance, ``negative for
premalignant or malignant changes'' and the second category
``premalignant or malignant lesions are present.'' This is
the approach used in the original CAP PAP program with its
``100 series'' and ``200 series.''
The CLIA'88 regulations concerning PTC, with their 4
diagnostic categories and complicated scoring system, do not
fit into the dichotomous scheme. Despite this fact, the
conclusions drawn by using the binomial error model regarding
PTC are applicable to any short test to a large extent.
Example of Simple Binomial Error Model
For the purpose of illustration, let us suppose, that in a
large population (for instance, that of an entire country),
the results from a scrupulous statistical survey using many
thousands of questionnaires and proper randomization indicate
that the proportion of individuals who like to watch
television (TV) is 90%. Because the survey is conducted in a
scientific way and the sample size is very large, this result
is considered highly accurate. The basic question on which
the analogy with PTC will be based is, ``What can we expect
if we ask 10 randomly selected individuals in this population
about their attitude toward TV?'' The most probable result
will be that, in this population, 9 of 10 individuals will
like TV. However, it is reasonable to expect that, in many
samples that consist of 10 individuals, all 10 individuals
are TV fans; whereas, in other similar samples, there may be
only 8, 7, or 6 such individuals. However, it is hardly
conceivable that we will identify as few as only 1 or 2 fans
in a sample of 10 individuals if the principle of random
selection is followed.
Random selection is important. For example, a nonrandom
sample, like one that consists exclusively of nuns in
convents, would not yield a statistically valid reflection of
the entire population; indeed, we may identify only 1 or 2
individuals in such a sample who like to watch TV. Exclusive
selection of nuns or members of any other group with some
special interest would not be compatible with the
principle of randomness. However, to select a nun
occasionally in a sample, with a frequency roughly
corresponding to the proportion of nuns in the entire
population, would be appropriate.
There is a statistical method that uses the so-called
``binomial formula'' for calculating the probability of
encountering 10, 9, 8, 7, etc, TV fans in a sample of 10
individuals from our postulated population. (This method is
not detailed in the current article, but an explanation can
be found in any elementary statistical textbook). The
probabilities even can be looked up in tables that are found
at the end of statistical books. Under the circumstances
outlined above (with a 90% proportion of TV fans in a sample
size of 10 individuals). the probabilities of identifying 10,
9, 8, 7, and 6 TV fans in a random sample of 10 individuals
are 0.35, 0.39, 0.19, 0.06, and 0.01, respectively.
The probability of identifying 5 TV fans under the above-
described circumstances in a truly random sample of 10
individuals is exceedingly small. The succession of numbers
described above represents a ``probability distribution,''
which can be observed in a histogram. This distribution is
interpreted as follows: If, from this very large population,
we take numerous random samples, each consisting of 10
individuals, and ask about their preferences for TV; then we
will find that 35% of the samples would include 10 fans, 39%
of the samples would include 9 fans, 19% of the samples would
include 8 fans, and so on.
If we change the size of the sample, then the magnitudes of
the single probabilities
and their distribution also will change and, along with them,
the probability distribution. If we choose sample sizes of
100 individuals instead of 10, then the probabilities will be
clustered much more tightly around the value of 90% than was
the case in the smaller samples. The larger the size of the
sample, the more reliable is the estimation; in other words,
the observed value in every sample approaches the real
population parameter. It is virtually unimaginable that there
will be only 50 or 60 TV fans among 100 randomly selected
individuals from this population. (Distribution data for such
large samples are not provided even in the tables of larger
statistical reference books: They are not needed, because the
probability distribution for large samples can be found by
the so-called ``normal approximation of the binomial
distribution.'' To perform this method is mathematically
simple, but the results may be slightly inaccurate. There are
complex Web-based Internet tools, however, that calculate
these probabilities very accurately.) Of course this holds
true only if the randomness principle is strictly observed.
How can we apply the reasoning described above to the issue
of sample sizes in PTC? Fortunately, the results of these
binomial calculations can be generalized. The reason why we
can do this is that, if the ``experiment'' qualifies as
binomial, then the specifics of the experiment, whether they
are related to liking TV or to success in PTC, have no
bearing on the values of the probabilities or on the
probability distribution.
True Scores
At this point, we need to review the term ``true score,'' a
concept that is used widely in modern test theory. The true
score of a hypothetical examinee is defined as the average of
the observed or measured scores that would be obtained over
an infinite number of repeated testing by the same test,
provided that the examinee's skills remain indefinitely
stable. For actual examinees, the true score can be estimated
with a small error margin, but its exact value is essentially
unknowable. For instance, if a cytologist screens 100,000
cervical smears, and if his or her diagnoses are correct
98,000 times, then the approximation of his or her true score
is 0.98. Because the accurate determination of the true score
would require an infinite number of repeat testing, which is
not feasible, this true score of 0.98 remains an
approximation. Obviously, we can be rather sure that, when
the same individual screens the next 100,000 preparations,
the approximation of his or her true score will not remain
the same: The chances of this are infinitesimally small. The
estimate of the true score will almost certainly change
slightly, for instance to 0.97 or to 0.99, and so on, for
each successive trial.
It has to be emphasized that assignment of an exact ``true
score'' to a cytologist is somewhat arbitrary for further
reasons. It cannot be expected that anybody's cytologic
skills will remain invariant for a prolonged time. We can
hope, of course, that the professional prowess of cytologists
improves over time. Furthermore, everybody who has ever
screened cytology specimens knows that screening performance
depends on many factors, some of which are extraneous to the
level of cytology skills. On a ``good'' day, a cytologist may
function on a 0.98 score level; whereas, on a different,
``bad'' day, he or she might be less ``proficient.'' Even his
or her experience with particular kinds of cytologic
presentations on the previous day, for example, having seen
an unusual presentation of high-grade squamous
intraepithelial lesion on a quality-assurance review, could
affect decision-making on the current day. Of course, these
and other psychological variables (eg, the effects of anxiety
or tiredness during tests or routine work) cannot be factored
into the statistical considerations. Nagy and Collins,
describing this concept, used the term ``competence level''
instead of ``true score'' in their 1991 article.
Direct measurement of the true score is not possible. What
we have after an evaluation of test results is the ``observed
score,'' which is related to the true score but is not
identical to it. It can be considered an estimate of the true
score.
Comparison of TV Preference and PTC Results
TV preference and PTC results can be compared as follows:
The values derived by the binomial formula are determined
only by the number of trials and the probability of success.
If the ``experiment'' qualifies as binomial, then the
specifics of the experiment have no bearing on the numerical
results. (In statistical parlance, any methods or procedures
that yield raw data are called experiments.) In our TV
example, the number of trials (the sample size) is 10, and
the probability of success is 0.9. These 2 data are
sufficient to calculate the probability distribution for this
specific case. Let us consider now an example of PTC in which
these specifics are the same as described above. The PTC
design prescribes 10 slide test sets (number of trials). A
cytologist who performs routine screening and customarily
renders accurate diagnoses 9000 times among 10,000 screened
slides has an approximate true score of 0.9. (In other words,
the probability of success is 0.9.) When this cytologist
attempts to pass this particular PTC, then the probability
distribution of the possible correct answers will be
identical to the probability distribution observed in the TV
example, because the specifics of the TV experiments are the
same. If this hypothetical cytologist attempts the test many
times, then he or she will read 10 slides correctly in 35% of
the tests, 9 slides correctly in 39% of the tests, and so on.
The numerical values in the 2 experiments are identical.
We also should note that, if an examinee reads 10 slides or
9 slides correctly:which happens in 74% of events under the
circumstances described above, then he or she passes the
test. However, this individual, who essentially has an
adequate true score, will fail a dichotomous PTC 26% of the
time because of the low validity and reliability of the test.
The phenomenon of failure in this case can be called ``type 1
error.'' (The null hypothesis is that ``the cytoscreener is
competent.'') A valid and reliable test is expected to pass
virtually all cytoscreeners with true scores on the 0.9
level; however, any dichotomous test that consists of 10
slides or challenges will misclassify approximately 26% of
such individuals. It is obvious that this test does not
really meet the expectation to determine the competence of an
examinee who had a true score of 0.9.
It needs to be reiterated here that binomial calculations
can be performed only for dichotomous tests. The
probabilities for some well ordered, nondichotomous tests may
be calculated by the use of more complicated multinomial
assessments.
Limitations of the Simple Binomial Error Model
The binomial error model provides only a rough appraisal of
the statistical factors that need to be taken into account in
the design of PTC. One of the drawbacks of the model, as
mentioned above, is that it is applicable only to
dichotomous testing systems. However, the simplicity,
transparency, and mathematical calculability of
dichotomous setups counterbalance every other
consideration. The dichotomous test design makes it
possible to assess the impact of test set size on test
validity and reliability and to calculate confidence
intervals. Thus, the use of a dichotomous test would
confer greater predictability and practicability to PTC.
The effects on test validity and reliability of a
haphazard design, like the CLIA'88-mandated PTC, hardly
are calculable by scientific-statistical means. We do not
state that dichotomous designs would solve every problem
inherent in every type of test, including PTC. However,
given that all other conditions of the testing are equal,
dichotomous tests have insurmountable advantages over
nondichotomous tests.
Size of Test Sets and Rate of Misclassification
Figures (not shown) illustrate the probability
distributions of correct diagnoses for variable test set
sizes and for examinees with different theoretical ``true
scores.'' An ideal and flawless PTC would fail all examinees
with true scores of 0.85, but no test design can fulfill such
requirements. The reliability of the tests improves, however,
as the test sets get larger. For examinees with true scores
of 0.85 or 0.8, the accuracy of the test increases in
parallel with the increasing size of the test sets. (The
failure rates become larger for larger test sets.)
Visualization of the effect of sample size on
misclassification also is possible by tabulation. The more
slides the test set contains, the lower the misclassification
rate. There appear to be anomalies at the set sizes of 9 and
19, in which the misclassification rate decreases for
examinees with low true scores and increases for the more
competent examinees. A test set that consists of 9 or 19
slides would be a very impractical choice. If the passing
level is set at 90% (eg, 9 correct answers for 10 slides in
dichotomous tests), as it is the general practice for PTCs,
then 1 error is allowed for a 10-slide set. Under these
circumstances, to pass a test based on 9-slide sets with a
90% passing grade would be incomparably more difficult than
to pass a test based on a 10-slide set, because a single
mistake would mean an error >10% and, consequently, a
failure. The situation is similar for 19- or 29-slide sets.
The greater grade of difficulty with a 9-slide test set is
reflected in the smaller passing rates for both competent and
less competent examinees. (This circumstance, paradoxically,
improves the accuracy of the test for the participants with
low true scores.) For these reasons, if the passing level is
set at 90%, then only decimal-based test set sizes (10, 20,
30, etc. slides or challenges) should be used.
Another observable phenomenon is the ``law of diminishing
returns,'' in which, as the number of slides in the test sets
is increases, the misclassification rates decrease. However,
the rate of decrease is not level but trails off with
increasingly larger set sizes. For instance,
misclassification of examinees with a true score of 0.8 is
almost halved, from 38% to 20%, when the number of slides in
the sets increases from 10 to 20. The next step, from a 20-
slide set to a 30-slide set, is accompanied by a smaller
relative improvement, and so on.
An important conclusion that can be drawn is that, when the
number of slides is increased in the test sets, the decrease
in the misclassification rate is more precipitous if the true
score is 0.8 or 0.85, ie, on the side of the table for less
competent examinees, than if the true score is 0.95. From our
viewpoint, this is an advantage. The basic purpose of PTC is
not the confirmation of the proficiency of the average
cytologist who performs well but the identification of
individuals who may have problems with expertise and need
remediation. The type 1 error, the failure of competent
examinees, is less consequential than the type 2 error, the
passing
of less competent examinees. The simple binomial model is
more suitable to investigate the latter than the former in
the set-size ranges that are prevalent in the practice of
I thank the distinguished whip for yielding. On Monday, the House is not in session. On Tuesday, the House will meet at 12:30 for morning hour and 2 p.m. for legislative business, with votes…
I thank the distinguished whip for yielding.
On Monday, the House is not in session. On Tuesday, the House will meet at 12:30 for morning hour and 2 p.m. for legislative business, with votes postponed until 6:30 p.m.
On Wednesday and Thursday, the House will meet at 10 a.m. for legislative business. On Friday, no votes are expected.
We will consider several bills under suspension of the rules, including several important public health bills, H.R. 2464, the Wakefield Act, and H.R. 1237, the Cytology Proficiency Improvement Act. The final list of bills under suspension of the rules will be announced by the close of business tomorrow.
In addition, we will consider H.R. 2016, the National Landscape Conservation System Act, and H.R. 2537, a bill to amend the Federal Water Pollution Control Act relating to beach monitoring.
I thank the gentleman for yielding.
It's our expectation that, following the testimony of General Petraeus and Ambassador Crocker, the committees will be meeting to not only discuss substantive policy, but also to discuss the supplemental appropriation bill. It would be my expectation that that bill would be on the floor either the end of April or the first week in May. We are cognizant, as the gentleman indicated, of the June period, and so we want to move this significantly before that debate so that there will not be any lag.
I thank the gentleman for yielding.
Well, there are obviously needs in addition to Iraq that are being discussed, and I would tell my friend that those discussions are ongoing. A decision on what may or may not be added in addition to the supplemental that may be necessary for Iraq, there may be other things, that decision has not been made at this point in time. But I do want to let the gentleman know that that is under discussion.
As the gentleman will recall, last year, when we passed the supplemental, there were domestic priorities that were also addressed, in particular, Katrina, as the gentleman will recall, and some other matters as well. So, that's under discussion.
As you know, we are strong proponents of the PAYGO rule and have adhered to that in all but one instance last year. We did not adhere to it, as you know, with the stimulus package. There was concern, and obviously we didn't want to stimulate and depress at the same point in time, so that was under discussion. But I will tell you on the housing bill itself, Mr. Frank has been working on that with his committee, Maxine Waters and others, and with Mr. Bachus and others on the committee. And we would certainly hope to move a housing bill in the near term, certainly no later than the latter part of this month or the very first days of the next month, so that we can pass a bill that would give relief to those who have either been foreclosed upon or are on the brink of foreclosure. We believe that it is essential for us to try to address what is a national problem and a very serious one. And so, that will also go into the consideration, I think, of how much money is needed, how that will be paid for.
Thank you very much for yielding.
I will say that over the last 7 years, the President has told us things are pretty good. There was never a right time for revenues to be increased. Even in the times when the President was telling us the economy was robust, we were growing, we still weren't paying our bills.
We feel very strongly on this side of the aisle, and Mr. Bernanke, in a telephone conversation with me, said one of the things we didn't want to do, when you and I and Mr. Boehner and Ms. Pelosi were talking about the stimulus package, one thing we did not want to do is exacerbate the long-term debt that confronts us. Mr. Bernanke is very concerned about that. But certainly in the context of wanting to move quickly in an emergency way where we have an economy now that Mr. Bernanke, although he didn't say it was a recession, he certainly gave the implication that we were on the brink of that, we're very concerned about the economic policies, very frankly, that we think have led to that.
But I will say that we have two concerns: Number one, paying for what we buy, not exacerbating the deficit. But clearly we're concerned about getting relief to people that need it in the short term. But my discussions with Mr. Bernanke were, yes, tax increases in the short term he thought were not helpful, but he wanted to make it very clear that he thought making the debt worse over the long term, whether it's for international expenses or domestic expenses, was not helpful to the economy in the long term.
I thank my friend for yielding.
I won't debate that now, but I would be interested in discussing it at some point in time because, as you know, in those years revenues fell short of the administration's projections in the previous years. So that, although revenues did increase, you're absolutely correct, as revenues have every year over the last 50 except for 2, they increased less than the administration had projected.
I thank the gentleman for the question.
We all agree this is an important agreement, but as you know, there are still major long-standing issues to be resolved, violence being one of them, labor rights being another, trade adjustment assistance, which the gentleman referred to, as another. If the White House does choose to send up the agreement, we will discuss the full range of options available to us under the TPA and the House rules.
I thank the distinguished gentleman from New York, and I thank the original author of this legislation, the gentleman from Tennessee (Mr. Davis), and I thank the distinguished Speaker for her…
I thank the distinguished gentleman from New
York, and I thank the original author of this legislation, the gentleman from Tennessee (Mr. Davis), and I thank the distinguished Speaker for her leadership as well, and my colleagues.
Congressman Higgins, this is Juneteenth Week for those of us who come from the States in which we honor this very special holiday. And so it is very special to stand today to acknowledge how important, how moving a time this is, particularly in the State of Texas where Major Granger landed in Galveston 2 years after the Emancipation Proclamation, which means that the slaves that were held in the State of Texas were held 2 years longer than any slaves in the United States in the region in which slavery was the law. I would like to acknowledge Rep. Al Edwards who is the Father of the Juneteenth Holiday in Texas.
So we hold this as a sacred time, a time of jubilee and celebration, but also of pain and anguish for knowing that we were held in bondage in the State of Texas for a period of time longer than the time that was declared by the President of the United States, Abraham Lincoln.
I'm delighted to be one of the original cosponsors to acknowledge what this day really means. And as we celebrate it throughout the week in Texas, this past weekend I celebrated with the Acres Home Community and their Juneteenth celebration and the Zydeco music and the fun that seniors and children alike would have in fellowship and understanding our history.
And many people don't recognize that it is as important a date as might be days that we commemorate Black History Month, special days such as the acknowledgment and the celebration of the birthday of Dr. Martin Luther King, or the 40th anniversary of the signing of the Civil Rights bill or the March on Washington or the tragic assassination of Dr. King, and this happens to be the 40th year.
It is a time when we renew ourselves in having a respect for freedom. And Major Granger, who came and acknowledged, gave way to decades and years of celebration.
He also gave way to something called Freedom Watch on New Year's Eve. Many people believe that is a celebration for the new year. But in old years or years back, black churches used to watch on New Year's Eve calling it Freedom Watch to be able to celebrate freedom; and it was the idea of knowing that on January 1, 1863, the slaves would be free.
This is a time to acknowledge that our history should be remembered, that we should teach it to our children, that we should take this history to ourselves, if we will, embed it in our hearts and our souls, and make sure that as we embed it, that we live what this history stands for. It stands for determination, tenacity, strength, character, integrity.
And we must fight against all of these things that enslave us now, and that is, of course, drugs and crime and poverty. And I hope that this Congress, in passing this legislation, will renew our commitment to ridding this Nation of drugs and the devastation of how it destroys families and that we will commit ourselves to building housing, we will commit ourselves to educating our children, we will commit ourselves to building our families, we will commit ourselves to peace, because that's what an emancipation means: Emancipating yourselves from things that were wrong, that were ill.
The Emancipation Proclamation rid this Nation of slavery. Its dastardly effects still continue even today as it separates races and religions, but we have a commitment as the United States Congress to use this floor today to be able to stand against what was a horrific time in the history of America where we held slaves, we debased them, and we rejected humanity and human rights and dignity; but now we must come and respect through this resolution.
So I thank the Congressman for his leadership on managing this bill. I particularly pay tribute to my colleague and friend, Congressman Danny Davis, and to all of my constituents in the State of Texas who will now celebrate this day with a gospel celebration on Saturday, a parade on Saturday, and many, many family reunions around the idea of being emancipated.
Let us live freedom. Let us stand for freedom by building this Nation free of the ills of drugs and poor housing and poverty and war, and that will truly be a commemoration of Juneteenth because Juneteenth is a freedom, and it is emancipation.
Mr. Speaker, I ask to address the House for one minute for the purpose of inquiring about next week's schedule. Mr. Speaker, I yield to my friend, the majority leader, for information about the…
Mr. Speaker, I ask to address the House for one minute for the purpose of inquiring about next week's schedule.
Mr. Speaker, I yield to my friend, the majority leader, for information about the schedule for next week.
I thank the gentleman for that.
I have a couple of questions on things that we haven't discussed. First of all, the supplemental budget, I know General Petraeus is in Washington next week, and I believe Ambassador Crocker. The President sent up a supplemental request in February of last year. By approximately June of this year we're told that the Army will run out of money, and that by July, their ability to use transfer authority will be exhausted. I wonder at what point, in conjunction with or following the Petraeus visits next week, does the leader think we will be talking about that supplemental request.
And I yield.
I thank the gentleman for that. I think that date is important, and we need to be sure and be aware of it as we move through this process, as you are.
The spending bill, I know as this administration comes to an end, I'm confident that the White House has had lots of requests from the administration side for additional spending, which I believe they have held the line on. Does the gentleman have a sense of whether this bill will be able to be contained to the defense supplemental, or will it possibly get bigger than that?
And I would yield.
Well, I do appreciate that. And I just say for my friend's information that we've certainly discouraged the White House, we're hoping, not only discouraged them from moving forward with any new additions, and I think they have decided not to do that and will be concerned about this going as quickly as possible and meeting these defense needs rather than being tied down.
Another topic is housing. On the other side of the building they've been talking about housing this week. I know that Chairman Frank has some proposals on housing. I really have two questions there: One, when do you anticipate some housing legislation on the floor? And two would be, do you expect that that housing legislation will follow the PAYGO rules of this Congress, or will those rules be suspended for that housing discussion?
And I would yield.
I think in that time frame there is a chance there will be some administrative actions taken as well, and that may be an important part of that debate.
I do know that this week Mr. Bernanke testified before the Joint Economic Committee, and part of his testimony was that he thought that this would be the wrong time for any tax increases. And I would hope we could maintain some openness on that PAYGO discussion as it relates to this housing concern that people are facing.
I would yield.
Well, I wouldn't quarrel with the gentleman about not having a good time for tax increases since '01 and '03, but revenue actually has increased during that period of time. I think in '05, '06 and '07 we may have set records of increased revenues, percentage over last year. So, you used the term revenue, and I think you meant taxes, because we did see some revenue increases during that time, and they were significant. I think over 14 percent in FY05, and double digits in the next 2 years.
I would yield.
Well, while we don't want to enter into this debate too fully, on the projections, even though
we still had deficits in those years, which I regret for a number of reasons, those deficits were always less at the end of the year than we had thought they were going to be at the beginning of the year because revenues exceeded projections. That's why the deficit was less.
The third topic, I think my last topic today, is, we're at a point in the congressional calendar where it's at least possible that, under the TPA, the Trade Promotion Authority rules, the President will send the Colombia Trade Agreement up because of the number of days left that under TPA would require a vote during the calendar we've put in place. And I wonder if the gentleman has a sense of whether the Colombia Trade Agreement process will go through the normal Trade Promotion Authority process, or if that process could possibly be shut off.
And I would yield.
I thank the gentleman, and I yield back.
Madam Speaker, I move to suspend the rules and agree to the resolution (H. Res. 1237) recognizing the historical significance of Juneteenth Independence Day, and expressing the sense of the House of…
Madam Speaker, I move to suspend the rules and agree to the resolution (H. Res. 1237) recognizing the historical significance of Juneteenth Independence Day, and expressing the sense of the House of Representatives that history should be regarded as a means for understanding the past and more effectively facing the challenges of the future.
Madam Speaker, I ask unanimous consent that all Members have 5 legislative days in which to revise and extend their remarks.
I yield myself such time as I may consume.
Madam Speaker, as a member of the House Committee on Oversight and Government Reform, I present for consideration H.R. 1237, which recognizes the historical significance of Juneteenth Independence Day, and expresses the sense of the House of Representatives that history should be regarded as a means for understanding the past and more effectively facing the challenges of the future.
H.R. 1237 was introduced on June 4, 2008, and has over 70 Members of Congress who also support Juneteenth, or what many call Freedom Day or Emancipation Day. The measure was considered and reported from the Oversight Committee on June 12, 2008, by voice vote, which brings us to today's floor consideration of the measure.
Most of us are aware, Madam Speaker, Juneteenth commemorates the day Union General Gordon Granger and 2,000 Federal troops arrived at the Galveston Island, Texas to take possession of the State and enforce the emancipation of its slaves 2\1/2\ years after the enactment of the Emancipation Proclamation.
On June 19, 1865 General Granger read the following Order Number 3: ``The people of Texas are informed that, in accordance with the proclamation from the Executive of the United States, all slaves are free. This involves an absolute equality of personal rights and rights of property between former masters and slaves, and the connection heretofore existing between them becomes that between employer and hired laborer. The freedmen are advised to remain quietly at their present homes and work for wages. They are informed that they will not be allowed to collect at military posts, and that they will not be supported in idleness either there or elsewhere.''
In receipt of this message, African Americans who had been slaves in the Southwest celebrated June 19 as the anniversary of their emancipation, and continued the tradition to inspire and encourage future generations.
For more than 135 years, Juneteenth Independence Day celebrations have been held to honor not only the freedom of African Americans but also to encourage self-development and respect for all cultures.
Juneteenth has been recognized as either a State holiday or observance in Texas, Oklahoma, Florida, Delaware, Idaho, Alaska, Iowa, California, Wyoming, Missouri, Connecticut, Illinois, Louisiana, New Jersey, New York, Colorado, Arkansas, Oregon, Kentucky, Michigan, New Mexico, Virginia, Washington, Tennessee, Massachusetts, and North Carolina, as well as the District of Columbia.
The faith and strength of character demonstrated by former slaves remains an example for all Americans, regardless of background, religion, or race.
Madam Speaker, I ask that we, too, show our support for Juneteenth Independence Day by agreeing to adopt H.R. 1237 without reservation.
I reserve the balance of my time.
Madam Speaker, I now yield to the gentlewoman from Texas (Ms. Jackson-Lee) for as much time as she may consume.
Madam Speaker, I urge passage, and I yield back the balance of my time.
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Madam Speaker, I move that the House suspend the rules and pass the bill (H.R. 1237) to amend the Public Health Service Act to provide revised standards for quality assurance in screening and…
Madam Speaker, I move that the House suspend the rules and pass the bill (H.R. 1237) to amend the Public Health Service Act to provide revised standards for quality assurance in screening and evaluation of gynecologic cytology preparations, and for other purposes, as amended.
Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous material on the bill under consideration.
Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in support of H.R. 1237, the Cytology Proficiency Improvement Act of 2007. This legislation would modernize Federal regulations under the Clinical Laboratory Improvement Amendments Act of 1988, CLIA, that subject those who screen and interpret Pap tests to annual proficiency testing.
In 2005, CMS launched a program to begin testing pathologists and other laboratory professionals who performed Pap tests for proficiency. However, the program was designed using regulations written in 1992. In the 13 years between the regulation and the program's start, significant investments were made in the science and practice of Pap tests. Instead of relying on outdated practices, H.R. 1237 draws on the best that science and technology has to offer.
H.R. 1237 has 175 bipartisan cosponsors, including myself and every other female member of the Energy and Commerce Committee. Additionally, this bill is supported by the College of American Pathologists, the American Medical Association, the American Clinical Laboratory Association, the American College of Obstetricians and Gynecologists, and the American College of Nurse Midwives.
I want to commend my colleagues, Representative Gordon and Representative Deal, for their hard work and commitment on this very important piece of legislation. This bill would improve the quality of women's health care. I strongly encourage all of our colleagues to join me in support of H.R. 1237.
Madam Speaker, I reserve the balance of my time.
Madam Speaker, I continue to reserve the balance of my time.
Madam Speaker, I have no further requests for time and again would like to commend my colleagues Representative Gordon and Representative Deal and also the Women's Caucus for their much hard work and commitment on this important piece of legislation.
This bill would improve the quality of women's health care, and I strongly encourage all of our colleagues to join in support of H.R. 1237.
Madam Speaker, I yield back the balance of my time.
Madam Speaker, I yield myself such time as I may consume. I, too, rise in support of the Cytology Proficiency Improvement Act. I was a sponsor of legislation similar to this in the last Congress…
Madam Speaker, I yield myself such time as I may consume.
I, too, rise in support of the Cytology Proficiency Improvement Act. I was a sponsor of legislation similar to this in the last Congress which passed the House, but unfortunately it was never signed into law. The bill revises national quality assurance standards of laboratories responsible for cytology services.
A few summers ago, I had the opportunity to visit a laboratory of a pathologist in my district, and I saw first hand the impact of this legislation. This bill is the result of actions taken in 2005 by the Centers for Medicare and Medicaid Services to institute a proficiency testing program for individual pathologists.
Unfortunately, this program was based on regulations first issued in 1992 as a result of the Clinical Laboratory Improvement Amendments of 1988. Thus the cytology proficiency program is now very outdated and based on regulations from nearly 15 years ago.
The legislation would provide for an orderly phase-out of the current program and transition into a new program where all individuals involved in screening and interpreting Pap tests would participate in a continuing medical education program in gynecologic cytology. This educational approach will present participants with complex cases to keep their skills on the cutting edge and will provide individuals an opportunity to test their skills.
I believe this legislation would be an important step in the right direction and would modernize the current regulatory framework while providing quality assurance, as was required in the Clinical Laboratory Improvement Amendments. Unlike last Congress, I hope we will be able to get this legislation signed into law in order to modernize an outdated proficiency testing program for pathologists.
Madam Speaker, I reserve the balance of my time.
Madam Speaker, I am pleased to yield 5 minutes to my colleague from Georgia (Mr. Price), one of the original cosponsors of the legislation this year, a medical doctor.
Madam Speaker, I urge the adoption of the bill.
Madam Speaker, I yield back the balance of my time.
Madam Speaker, I rise today in support of H.R. 1237, the Cytology Proficiency Improvement Act. I am pleased to see that the House will vote today on revamping a 16-year-old CMS regulation--from…
Madam Speaker, I rise today in support of H.R. 1237, the Cytology Proficiency Improvement Act. I am pleased to see that the House will vote today on revamping a 16-year-old CMS regulation--from 1992--that calls for a Federal program to test the proficiency of individual laboratory professionals who read Pap tests.
I first became aware of the need to revisit this outdated regulation several years ago, in 2005, when CMS first began implementation of the program long after it was first put on the books. Congress knows well that promulgating regulations and implementation can do more harm than good.
The current oversight model that CMS is using is intended to help ensure that Pap tests are being read accurately--to improve public health. However, the approach established more than a decade ago, and being used today, doesn't necessarily protect women, improve quality or further our fight against cervical cancer.
H.R. 1237 provides an alternative. It redirects the current ``testing'' scheme to require pathologists and other lab technicians who read Pap tests to participate in an annual continuing medical education, CME program where their skills would be assessed and where the latest advances in Pap test practice could be shared. It would complement extensive Pap test quality controls that labs must already meet under the Clinical Laboratory Improvement Act. The Mammography Quality Standards Act includes a similar CME approach.
I've talked to pathologists in my district to better understand what it would take to add value to their profession, rather than just more red tape. Dr. Jared Schwartz was one of those who educated me and lent his expertise. He is now serving as president of the College of American Pathologists and is a strong advocate for ensuring access to Pap tests for all women. The laboratory and medical community support this bill, and I'm pleased to support it.
Madam Speaker, I rise today in support of H.R. 1237, the Cytology Proficiency Improvement Act of 2007. I am a cosponsor of this important legislation, which enhances women's health by establishing a…
Madam Speaker, I rise today in support of H.R. 1237, the Cytology Proficiency Improvement Act of 2007. I am a cosponsor of this important legislation, which enhances women's health by establishing a continuing medical education requirement for pathologists and laboratory professionals who examine Pap tests to screen for cervical cancer.
I recently toured Sarasota Pathology and heard directly from my constituents about the importance of this bill and its potential to help save lives.
This legislation amends the Clinical Laboratory Improvements Amendments of 1988, CLIA, which mandated a cytology proficiency test to be administered by the Federal Government. However, the program lay inactive until 2005, which, because of scientific advancements makes the test obsolete and out of date.
Unlike the current CLIA testing model, H.R. 1237, with its annual continuing medical education requirement, will provide the means to increase the skills necessary to identify potential cervical cancer, and will keep pace with new science.
H.R. 1237 is modeled after the Mammography Quality Standards Act, MQSA, which was passed in 1992. That bill ensured women would have access to quality mammography procedures. This bill requires similar educational testing for pathologists.
The American Medical Association, the College of OBGYNs, the College of American Pathologists, the American Society for Clinical Pathology, the College of Nurse Midwifes, and the Cancer Research and Prevention Foundation endorse the bill.
Finally, I want to mention that the Congressional Budget Office has determined that it will not cost the Federal Government any additional expenditure.
Madam Speaker, I urge my colleagues to join with me in support of a bill that will greatly improve the quality of women's health care in America.
Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I, too, rise in support of this resolution. Certainly history is replete with examples like this where well- intended, strong…
Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I, too, rise in support of this resolution.
Certainly history is replete with examples like this where well- intended, strong statements are made and then as much as 2 years passes before the event becomes complete. Juneteenth is no exception to that.
More than 2 years after the Emancipation Proclamation, it took 2,000 Federal soldiers marching into Galveston Island in order to free slaves from servitude. So as we look at what we need to do here in Congress today, let us not be dissuaded from doing what is right because it may take time. Let us not be dissuaded from making sure that America has its freedom and independence assured by our own independence in all areas, including natural resources.
I certainly think more than 100 years after the Civil War, we can celebrate the successes of the Civil War; but we also have an obligation to deal with problems that might take 4 or 5 years of domestic exploration and domestic investment in oil and natural gas in order to bear fruit. But I would ask today that we resolve to begin that process because certainly, as we look at President Abraham Lincoln who knew that the Emancipation Proclamation would not immediately free slaves but, in fact, would make a strong statement that we were resolved to do so.
I would hope today as we pass this important piece of legislation, we would resolve to make sure that America is independent and free in the years to come.
With that, I reserve the balance of my time.
Madam Speaker, I have no further speakers, and I yield back the balance of my time.
Madam Speaker, I object to the vote on the ground that a quorum is not present and make the point of order that a quorum is not present.
Madam Speaker, I rise today in support of The Cytology Proficiency Improvement Act, H.R. 1237, which would modernize and improve a Federal program aimed at promoting quality cervical cancer…
Madam Speaker, I rise today in support of The Cytology Proficiency Improvement Act, H.R. 1237, which would modernize and improve a Federal program aimed at promoting quality cervical cancer screening. Pathologists are already required by Federal law under the Clinical Laboratory Improvement Amendments of 1988, CLIA, to comply with extensive quality assurance standards for Pap tests. The bill would complement CLIA by establishing a Federal continuing medical education, CME, requirement for pathologists and laboratory professionals who examine Pap tests to screen for cervical cancer.
I have been a long-time advocate of medical technology and education advancements. Earlier this year, I had the opportunity to tour the Pathology Lab at St. Francis Hospital in Wilmington, DE to get a first hand look at the practice and techniques used in Delaware. During the tour, the doctors and medical staff highlighted the need for H.R. 1237.
Regular screening can make all the difference in addressing cervical cancer and early detection can save lives. Women need access to the latest in Pap test science, principles of patient safety and technological advances such as computer-assisted screening, digital imaging, and HPV typing. Over the years, this educational requirement will also accommodate advances in science and technology without going through the long process of making changes in regulation.
I urge my colleagues on both sides of the aisle to support passage of The Cytology Proficiency Improvement Act, H.R. 1237.
Madam Speaker, I rise in strong support of House Resolution 1237, which recognizes the historic significance of Juneteenth Independence Day and encourages its continued celebration so all Americans…
Madam Speaker, I rise in strong support of House Resolution 1237, which recognizes the historic significance of Juneteenth Independence Day and encourages its continued celebration so all Americans can learn more about our country's past.
The resolution also rightly expresses the sense of Congress that knowing our history helps us solve challenges we face in the future, and that the celebration of the end of slavery is an important part of the history and heritage of the United States.
Madam Speaker, Juneteenth has long been recognized as the day to celebrate the end of slavery in the United States. Juneteenth is the traditional celebration of the day on which the last slaves in America learned they had been freed.
Although slavery was abolished officially in 1863, it took over 2 years for news of freedom to spread to slaves. On June 19th, 1865, U.S. General Gordon Granger rode into Galveston, Texas and announced that the State's 200,000 slaves were free. Vowing never to forget the date, the former slaves coined the nickname Juneteenth, a blend of the words June and 19th. This holiday originated in the Southwest, but today it is celebrated throughout the Nation.
H. Res. 1237 underscores that the observance of Juneteenth Independence Day is an opportunity for all Americans to learn more about our common past and to better understand the experiences that have shaped our great Nation. I urge my colleagues to support this important resolution.
Madam Speaker, I am pleased to support H. Res. 1237, legislation commemorating a monumental day in the history of liberty, Juneteenth Independence Day. Juneteenth marks the events of June 19, 1865,…
Madam Speaker, I am pleased to support H. Res. 1237, legislation commemorating a monumental day in the history of liberty, Juneteenth Independence Day. Juneteenth marks the events of June 19, 1865, when slaves in Galveston, Texas learned that they were at last free men and women. The slaves of Galveston were the last group of slaves to learn of the end of slavery. Thus, Juneteenth represents the end of slavery in America.
I hope all Americans will take the time to commemorate Juneteenth. Friends of human liberty should celebrate the end of slavery in any country. The end of American slavery is particularly worthy of recognition since there are few more blatant violations of America's founding principles, as expressed in the Declaration of Independence, than slavery. I am particularly pleased to join the recognition of Juneteenth because I have the privilege of representing Galveston.
I thank the gentleman from Illinois for introducing this resolution. I thank the House leadership for bringing this resolution to the floor, and I urge all of my colleagues to honor the end of slavery by voting for H. Res 1237.
Bill Text
4 versions available
[Congressional Bills 110th Congress]
[From the U.S. Government Printing Office]
[H.R. 1237 Referred in Senate (RFS)]
2d Session
H. R. 1237
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 9, 2008
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To amend the Public Health Service Act to provide revised standards for
quality assurance in screening and evaluation of gynecologic cytology
preparations, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Cytology Proficiency Improvement Act
of 2008''.
SEC. 2. REVISED STANDARDS FOR QUALITY ASSURANCE IN SCREENING AND
EVALUATION OF GYNECOLOGIC CYTOLOGY PREPARATIONS.
(a) In General.--Section 353(f)(4)(B)(iv) of the Public Health
Service Act (42 U.S.C. 263a(f)(4)(B)(iv)) is amended to read as
follows:
``(iv) requirements that each clinical
laboratory--
``(I) ensure that all individuals
involved in screening and interpreting
cytological preparations at the
laboratory participate annually in a
continuing medical education program in
gynecologic cytology that--
``(aa) is approved by the
Accrediting Council for
Continuing Medical Education or
the American Academy of
Continuing Medical Education;
and
``(bb) provides each
individual participating in the
program with gynecologic
cytological preparations (in
the form of referenced glass
slides or equivalent
technologies) designed to
improve the locator,
recognition, and interpretive
skills of the individual;
``(II) maintain a record of the
cytology continuing medical education
program results for each individual
involved in screening and interpreting
cytological preparations at the
laboratory;
``(III) provide that the laboratory
director shall take into account such
results and other performance metrics
in reviewing the performance of
individuals involved in screening and
interpreting cytological preparations
at the laboratory and, when necessary,
identify needs for remedial training or
a corrective action plan to improve
skills; and
``(IV) submit the continuing
education program results for each
individual and, if appropriate, plans
for corrective action or remedial
training in a timely manner to the
laboratory's accrediting organization
for purposes of review and on-going
monitoring by the accrediting
organization, including reviews of the
continuing medical education program
results during on-site inspections of
the laboratory.''.
(b) Effective Date and Implementation; Termination of Current
Program of Individual Proficiency Testing.--
(1) Effective date and implementation.--Except as provided
in paragraph (2), the amendment made by subsection (a) applies
to gynecologic cytology services provided on or after the first
day of the first calendar year beginning 1 year or more after
the date of the enactment of this Act, and the Secretary of
Health and Human Services (hereafter in this subsection
referred to as the ``Secretary'') shall issue final regulations
implementing such amendment not later than 270 days after such
date of enactment.
(2) Termination of current individual testing program.--The
Secretary of Health and Human Services shall terminate the
individual proficiency testing program established pursuant to
section 353(f)(4)(B)(iv) of the Public Health Service Act (42
U.S.C. 263a(f)(4)(B)(iv)), as in effect on the day before the
date of the enactment of subsection (a), at the end of the
calendar year which includes the date of enactment of the
amendment made by subsection (a).
Passed the House of Representatives April 8, 2008.
Attest:
LORRAINE C. MILLER,
Clerk.